510(k) K120789 ยท IYE Accelerator, Linear, Medical
EXACTRAC X-RAY X-RAY
| Applicant | Brainlab AG, Feldkirchen, DE |
| Decision | Substantially Equivalent, Aug 14, 2012 |
| Received | Mar 15, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2018 | Brainlab AG ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy Terminated |
IYE | None listed |
| Aug 21, 2015 | Brainlab AG ExacTrac 6.0.x
Patient Positioning System, Radiation therapy.
Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic Terminated |
IYE | None listed |
| May 6, 2015 | Brainlab AG ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Terminated |
IYH | None listed |
| Mar 25, 2015 | Brainlab AG ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Terminated |
IYE | None listed |
| Aug 4, 2014 | Brainlab AG ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order t Terminated |
IYE | None listed |
| Apr 25, 2014 | Brainlab AG ExacTrac 6.0 is a patient positioning and monitoring system.
Model/catalogue numbers:
20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE
49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3
49926B ET UPGRADE SOFTWARE 3. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.